NL-OMON40807已完成不适用
HeartMate PHP CE Mark Clinical Investigation - HeartMate PHP
Thoratec Corporation0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- At least 18 years of age.
- •- Patient presents with a non-emergent need for complex PCI with:
- •1) an ejection fraction of <=35% requiring hemodynamic support during the procedure,
- •2) the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
- •- Written, signed, and dated informed consent
排除标准
- •- Emergent PCI
- •- ST elevation myocardial infarction within 7 days of procedure
- •- Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
- •- Hemodynamic support with the HeartMate PHP post-PCI is anticipated
- •- Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index <2.2 L/min/m2)
- •- Mural thrombus in the left ventricle
- •- History of aortic valve replacement
- •- Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
- •- Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher )
- •- Severe peripheral vascular disease
- •- Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
- •- Planned use of rotablator or atherectomy during the procedure
- •- Serum creatinine > 3.5mg/dL within 7 days of procedure
- •- Liver dysfunction with elevation of liver enzymes and bilirubin levels to >= 3x ULN or INR (Internationalized Normalized Ratio) >= 2
- •- Uncorrectable abnormal coagulation parameters
- •- Active systemic infection requiring treatment with antibiotics
- •- Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction
- •- Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
- •- History of heparin induced thrombocytopenia.
- •- Patient is pregnant or planning to become pregnant during the study period
- •- Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
研究者
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